Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

novo nordisk pharma (malaysia) sdn. bhd. - insulin aspart; insulin degludec -

Philippines - English - FDA (Food And Drug Administration)

novo nordisk pharmaceuticals (philippines), inc.; distributor: novo nordisk pharmaceuticals (philippines), inc. - insulin aspart - suspension for injection (sc) (30% insulin aspart and 70% insulin aspart protamine) - 100 u/ml (3.5 mg/ml)

Israel - English - Ministry of Health

novo nordisk ltd., israel - insulin aspart - solution for injection - insulin aspart 100 u/ml - insulin aspart - treatment of patients with diabetes mellitus in adults, adolescents and children aged 2 years and above.

Israel - English - Ministry of Health

novo nordisk ltd., israel - insulin aspart - suspension for injection - insulin aspart 100 u/ml - insulin aspart - novomix 70 is indicated for treatment of diabetes mellitus in adults.

United States - English - NLM (National Library of Medicine)

a-s medication solutions - insulin aspart (unii: d933668qvx) (insulin aspart - unii:d933668qvx) - novolog mix 70/30 is a mixture of insulin aspart protamine and insulin aspart indicated to improve glycemic control in adult patients with diabetes mellitus. limitations of use: novolog mix 70/30 is contraindicated: risk summary there are no available data with novolog mix 70/30 in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. available information from published randomized controlled trials with insulin aspart use during the second trimester of pregnancy have not reported an association with insulin aspart and major birth defects or adverse maternal or fetal outcomes [see data] . there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see clinical considerations] . in animal reproduction studies, administration of subcutaneous insulin aspart to pregnant rats and rabbits during the period of organogenesis did not cause adverse developmental effects at exposures 8-times and equal to the human subcutaneous dose of 1 unit/kg/day, respectively. pre- and post-implantation losses and visceral/skeletal abnormalities were seen at higher exposures, which are considered secondary to maternal hypoglycemia. these effects were similar to those observed in rats administered regular human insulin [see data] . the estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a hba1c >7% and has been reported to be as high as 20-25% in women with a hba1c >10%. the estimated background risk of miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and/or embryo-fetal risk poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications. poorly controlled diabetes increases the fetal risk for major birth defects, still birth, and macrosomia related morbidity. data human data published data from 5 randomized controlled trials of 441 pregnant women with diabetes mellitus treated with insulin aspart during the late 2nd trimester of pregnancy did not identify an association of insulin aspart with major birth defects or adverse maternal or fetal outcomes. however, these studies cannot definitely establish the absence of any risk because of methodological limitations, including a variable duration of treatment and small size of the majority of the trials. animal data fertility, embryo-fetal and pre- and postnatal development studies have been performed with insulin aspart and regular human insulin in rats and rabbits. in a combined fertility and embryo-fetal development study in rats, insulin aspart was administered before mating, during mating, and throughout pregnancy. further, in a pre- and postnatal development study insulin aspart was given throughout pregnancy and during lactation to rats. in an embryo-fetal development study insulin aspart was given to female rabbits during organogenesis. the effects of insulin aspart did not differ from those observed with subcutaneous regular human insulin. insulin aspart, like human insulin, caused pre- and post-implantation losses and visceral/skeletal abnormalities in rats at a dose of 200 units/kg/day (approximately 32 times the human subcutaneous dose of 1 unit/kg/day, based on human exposure equivalents) and in rabbits at a dose of 10 units/kg/day (approximately three times the human subcutaneous dose of 1 unit/kg/day, based on human exposure equivalents). no significant effects were observed in rats at a dose of 50 units/kg/day and in rabbits at a dose of 3 units/kg/day. these doses are approximately 8 times the human subcutaneous dose of 1 unit/kg/day for rats and equal to the human subcutaneous dose of 1 unit/kg/day for rabbits, based on human exposure equivalents. the effects are considered secondary to maternal hypoglycemia. risk summary there are no data on the presence of novolog mix 70/30 in human milk, the effects on the breastfed infant, or the effect on milk production. one small published study reported that exogenous insulin, including insulin aspart, was present in human milk. however, there is insufficient information to determine the effects of insulin aspart on the breastfed infant. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for novolog mix 70/30, and any potential adverse effects on the breastfed infant from novolog mix 70/30, or from the underlying maternal condition. safety and effectiveness of novolog mix 70/30 have not been established in pediatric patients with diabetes mellitus. clinical studies of novolog mix 70/30 did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger adult patients. in geriatric patients with diabetes, the initial dosing, dose increments should be conservative to avoid hypoglycemic reactions. hypoglycemia may be difficult to recognize in geriatric patients. the effect of renal impairment on the pharmacokinetics of novolog mix 70/30 has not been studied. some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure. patients with renal impairment may be at increased risk of hypoglycemia and may require more frequent novolog mix 70/30 dose adjustment and more frequent blood glucose monitoring [see warnings and precautions (5.3)]. the effect of hepatic impairment on the pharmacokinetics of novolog mix 70/30 has not been studied. patients with hepatic impairment may be at increased risk of hypoglycemia and may require more frequent novolog mix 70/30 dose adjustment and more frequent blood glucose monitoring [see warnings and precautions (5.3)].

United States - English - NLM (National Library of Medicine)

a-s medication solutions - insulin aspart (unii: d933668qvx) (insulin aspart - unii:d933668qvx) - novolog mix 70/30 is a mixture of insulin aspart protamine and insulin aspart indicated to improve glycemic control in adult patients with diabetes mellitus. limitations of use: novolog mix 70/30 is contraindicated: risk summary there are no available data with novolog mix 70/30 in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. available information from published randomized controlled trials with insulin aspart use during the second trimester of pregnancy have not reported an association with insulin aspart and major birth defects or adverse maternal or fetal outcomes [see data] . there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see clinical considerations] . in animal reproduction studies, administration of subcutaneous insulin aspart to pregnant rats and rabbits during the period of organogenesis did not cause adverse developmental effects at exposures 8-times and equal to the human subcutaneous dose of 1 unit/kg/day, respectively. pre- and post-implantation losses and visceral/skeletal abnormalities were seen at higher exposures, which are considered secondary to maternal hypoglycemia. these effects were similar to those observed in rats administered regular human insulin [see data] . the estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a hba1c >7% and has been reported to be as high as 20-25% in women with a hba1c >10%. the estimated background risk of miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and/or embryo-fetal risk poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications. poorly controlled diabetes increases the fetal risk for major birth defects, still birth, and macrosomia related morbidity. data human data published data from 5 randomized controlled trials of 441 pregnant women with diabetes mellitus treated with insulin aspart during the late 2nd trimester of pregnancy did not identify an association of insulin aspart with major birth defects or adverse maternal or fetal outcomes. however, these studies cannot definitely establish the absence of any risk because of methodological limitations, including a variable duration of treatment and small size of the majority of the trials. animal data fertility, embryo-fetal and pre- and postnatal development studies have been performed with insulin aspart and regular human insulin in rats and rabbits. in a combined fertility and embryo-fetal development study in rats, insulin aspart was administered before mating, during mating, and throughout pregnancy. further, in a pre- and postnatal development study insulin aspart was given throughout pregnancy and during lactation to rats. in an embryo-fetal development study insulin aspart was given to female rabbits during organogenesis. the effects of insulin aspart did not differ from those observed with subcutaneous regular human insulin. insulin aspart, like human insulin, caused pre- and post-implantation losses and visceral/skeletal abnormalities in rats at a dose of 200 units/kg/day (approximately 32 times the human subcutaneous dose of 1 unit/kg/day, based on human exposure equivalents) and in rabbits at a dose of 10 units/kg/day (approximately three times the human subcutaneous dose of 1 unit/kg/day, based on human exposure equivalents). no significant effects were observed in rats at a dose of 50 units/kg/day and in rabbits at a dose of 3 units/kg/day. these doses are approximately 8 times the human subcutaneous dose of 1 unit/kg/day for rats and equal to the human subcutaneous dose of 1 unit/kg/day for rabbits, based on human exposure equivalents. the effects are considered secondary to maternal hypoglycemia. risk summary there are no data on the presence of novolog mix 70/30 in human milk, the effects on the breastfed infant, or the effect on milk production. one small published study reported that exogenous insulin, including insulin aspart, was present in human milk. however, there is insufficient information to determine the effects of insulin aspart on the breastfed infant. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for novolog mix 70/30, and any potential adverse effects on the breastfed infant from novolog mix 70/30, or from the underlying maternal condition. safety and effectiveness of novolog mix 70/30 have not been established in pediatric patients with diabetes mellitus. clinical studies of novolog mix 70/30 did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger adult patients. in geriatric patients with diabetes, the initial dosing, dose increments should be conservative to avoid hypoglycemic reactions. hypoglycemia may be difficult to recognize in geriatric patients. the effect of renal impairment on the pharmacokinetics of novolog mix 70/30 has not been studied. some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure. patients with renal impairment may be at increased risk of hypoglycemia and may require more frequent novolog mix 70/30 dose adjustment and more frequent blood glucose monitoring [see warnings and precautions (5.3)]. the effect of hepatic impairment on the pharmacokinetics of novolog mix 70/30 has not been studied. patients with hepatic impairment may be at increased risk of hypoglycemia and may require more frequent novolog mix 70/30 dose adjustment and more frequent blood glucose monitoring [see warnings and precautions (5.3)].

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - insulin aspart (unii: d933668qvx) (insulin aspart - unii:d933668qvx) - novolog is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. novolog is contraindicated: - during episodes of hypoglycemia [see warnings and precautions ( 5.3)] - in patients with hypersensitivity to novolog or one of its excipients, [see warnings and precautions ( 5.5)] risk summary available information from published randomized controlled trials with insulin aspart use during the second trimester of pregnancy have not reported an association with insulin aspart and major birth defects or adverse maternal or fetal outcomes [see data] . there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see clinical considerations] . in animal reproduction studies, administration of subcutaneous insulin aspart to pregnant rats and rabbits during the period of organogenesis did not cause adverse developmental effects at

Philippines - English - FDA (Food And Drug Administration)

novo nordisk pharmaceuticals (phils.) inc.; distributor: novo nordisk pharmaceuticals (phils.) inc. - biphasic insulin aspart 50 - suspension for injection (sc) [1 ml of suspension contains 100 units soluble insulin aspart/protamine-crystallized insulin aspar - 100 u/ml

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - insulin lispro (unii: gfx7qis1ii) (insulin lispro - unii:gfx7qis1ii) - insulin lispro injection is a rapid acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus. insulin lispro injection is contraindicated: - during episodes of hypoglycemia - in patients who are hypersensitive to insulin lispro injection or to any of its excipients. risk summary the limited available data with insulin lispro injection in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. published studies with insulin lispro used during pregnancy have not reported an association between insulin lispro and the induction of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data) . there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations) . pregnant rats and rabbits were exposed to insulin lispro in animal reproduction studies during organogenesis. no adverse effects on embryo/fetal

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - insulin lispro (unii: gfx7qis1ii) (insulin lispro - unii:gfx7qis1ii) - insulin lispro injection is a rapid acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus. insulin lispro injection is contraindicated: - during episodes of hypoglycemia - in patients who are hypersensitive to insulin lispro injection or to any of its excipients. risk summary the limited available data with insulin lispro injection in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. published studies with insulin lispro used during pregnancy have not reported an association between insulin lispro and the induction of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data) . there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations) . pregnant rats and rabbits were exposed to insulin lispro in animal reproduction studies during organogenesis